A Cohort Study on the Association Between the ANS Function and Acute GvHD

January 23, 2026 updated by: Institute of Hematology & Blood Diseases Hospital, China

A Cohort Study on the Association Between the Autonomic Nervous System Function and Acute GvHD After Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation

This is a prospective observational study. The investigators plan to utilize this model as a tool for early classification and interrogate ANS function of transplant recipients.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300000
        • Recruiting
        • Institute of Hematology & Blood Diseases Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients receiving HLA-haploidentical transplants at the Institute of Hematology, Chinese Academy of Medical Sciences (IHCAMS)

Description

Inclusion Criteria:

  1. Patients must be > 16 years of age;
  2. Patients receiving HLA-haploidentical transplants;
  3. Patients have to sign an informed consent form before the start of the research procedure.

Exclusion Criteria:

  1. Tandem transplantation or multiple transplantations;
  2. Mental or other medical conditions that make the patients unable to comply with the research treatment and monitoring requirements;
  3. Patients who are ineligible for the study due to other factors, or will bear great risk if participating in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Adult patients receiving HLA-haploidentical transplants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Result of heart rate response to standing test
Time Frame: Within one month before the transplantation and during 17-25 days after the transplantation.
Autonomic nervous system functional tests including heart rate response to standing will be performed within one month before the transplantation and during 17-25 days after the transplantation.
Within one month before the transplantation and during 17-25 days after the transplantation.
Result of piloerection test
Time Frame: Within one month before the transplantation and during 17-25 days after the transplantation.
Autonomic nervous system functional tests including piloerection will be performed within one month before the transplantation and during 17-25 days after the transplantation.
Within one month before the transplantation and during 17-25 days after the transplantation.
Number of participants with abnormal dynamic electrocardiography readings
Time Frame: Within one month before the transplantation and during 17-25 days after the transplantation.
Dynamic electrocardiography will be performed within one month before the transplantation and during 17-25 days after the transplantation.
Within one month before the transplantation and during 17-25 days after the transplantation.

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of severe acute GvHD after transplantation within 100 days and incidences of acute GvHD (any grade) in various target organs.
Time Frame: 100 days after transplantation
100 days after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2025

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 28, 2025

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • IIT2025112

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Transplant-Related Disorder

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe